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FDA Inspection
•Novartis Pharmaceuticals Corporation•February 6, 2026

Novartis Pharmaceuticals Corporation – FDA Inspection, Feb 6, 2026

Record Details

This FDA Inspection record concerns Novartis Pharmaceuticals Corporation, with an inspection on February 6, 2026, issued by the New Jersey District Office, covering biologics.

Company
Novartis Pharmaceuticals Corporation
Inspection Date
February 6, 2026
Product Type
Biologics
Office
New Jersey District Office
People
  • Christian D. Lynch (Company Rep)
  • Christian Lynch (Issuing Officer)
  • Lizaida Perez (FDA Personnel)
View Company Profile

ID · dda9986d-7403-4915-9abe-66007c22736d

Inspection Facts

Inspection number
1300144
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 211.113(b)Procedures for sterile drug products
  2. 21 CFR 211.192Investigations of discrepancies, failures
  3. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Novartis Pharmaceuticals Corporation

4
DateClassificationOfficeProject area
August 8, 2024VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
December 9, 2022NAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
August 21, 2019VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
April 7, 2017Not classifiedNew Jersey District Office
Other documents for Novartis Pharmaceuticals Corporation
  • FDA Inspection 1245942 - 2024-08-08
  • FDA Inspection 1194474 - 2022-12-09
  • FDA Inspection 1100101 - 2019-08-21
  • FDA Inspection 1019194 - 2017-04-07

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